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Diss Factsheets
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EC number: 237-574-9 | CAS number: 13845-36-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
1. Both substances are inorganic salts of a monovalent cation from Group 1A of the periodic table, and triphosphoric acid. Thus, they share the Na+ or K+ cation and P3O105- anion.
2. As both substances contain the same anion, any sensitisation potential from the anion will be the same for both compounds.
3. Sodium and potassium are both group 1 alkali metals, the ionic charges are the same and the chemical behaviour will be similar. Potassium has a larger ionic radius and as penetration of the skin is largely governed by molecular size, the ability of potassium to penetrate the skin is likely to be less than sodium. As the chemical behaviour of both the anion and the cation will be similar and the dermal absorption of the cation is likely to be reduced, the negative results from pentasodium triphosphate can reliably be read across to pentapotassium triphosphate.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.
4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Pentasodium triphosphate
- EC Number:
- 231-838-7
- EC Name:
- Pentasodium triphosphate
- Cas Number:
- 7758-29-4
- Molecular formula:
- Na5P3O10 H5-xP3O10Nax (where x is approximately 5) 6H2O.Na5P3O10
- IUPAC Name:
- Pentasodium triphosphate
- Details on test material:
- - Name of test material (as cited in study report): Sodium tripolyphosphate (STPP)
- Physical state: White solid
- Storage condition of test material: Room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK limit
- Age at study initiation:
- Weight at study initiation: 15-23g
- Housing: individually in suspended solid floor polypropylene cages
- Diet (e.g. ad libitum): certified rat and mouse diet ad libitum
- Water (e.g. ad libitum):mains tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25-30
- Humidity (%): 19-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 04/03/2008 To: 26/04/2008
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% pluronic L92 in distilled water
- Concentration:
- 1, 2.5 and 5%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:LLNA
- Criteria used to consider a positive response:Test material regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in HTdR incorporation compared to control values
TREATMENT PREPARATION AND ADMINISTRATION: Freshly prepared in 1% pluronic L92 in distilled water
daily application of 25µl of 1, 2.5 or 5% w/w test material - Positive control substance(s):
- other: 2,4-Dinitrobenzenesulfonic acid, sodium salt
Results and discussion
- Positive control results:
- 2,4-dinitrobenzenesulfonic acid, sodium salt in 1% pluronic L92 in distilled water
Concentration, Stimulation index, Result
1%, 1.80, Negative
5%, 4.32, Positive
10% , 11.98, Positive
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.27
- Test group / Remarks:
- 1% w/w in vehicle
- Key result
- Parameter:
- SI
- Value:
- 1.17
- Test group / Remarks:
- 2.5% w/w in vehicle
- Key result
- Parameter:
- SI
- Value:
- 1.31
- Test group / Remarks:
- 5% w/w in vehicle
Any other information on results incl. tables
Table 1. Results of the Local Lymph Node Assay.
Concentration (% w/w) in 1% pluronic L92 in distilled water |
DPM |
DPM/node |
Stimulation index |
Results |
Vehicle |
2501.00 |
312.63 |
n.a. |
n.a. |
1 |
3176.25 |
397.27 |
1.27 |
Negative |
2.5 |
2938.16 |
367.27 |
1.17 |
Negative |
5 |
3279.54 |
409.94 |
1.31 |
Negative |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test. The study is considered to be reliable and acceptable for use as a key study for read across to pentapotassium triphosphate (potassium tripolyphosphate).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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